Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)

Phase 3

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01446029
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

Brief Summary

The purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.

Detailed Description

Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US population has CKD with an increased prevalence among individuals great than 65years. Many individuals with CKD go unrecognized because they are typically asymptomatic. Individuals with CKD have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. Also, individuals with CKD consume a significantly greater proportion of health care expenditures compared to other patients. This study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, ER visits or admission to a skilled nursing facility in patients with CKD compared to usual care. This study will use a randomized controlled trial. Few interventions have been demonstrated to improve clinical outcomes in patients with CKD. If successful, this study will enable the VA to provide high quality care to patients with CKD while potentially reducing the cost of providing care.

Study Timeline

• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-04
• Study Start: 2012-03
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

Enrolled at Minneapolis or St. Cloud Veterans Affairs Health Care System (VAHCS) or affiliated Community Based Outcomes Clinic(CBOC); Late eGFR within the VA system <60 ml/min/1.73m2 -

Exclusion Criteria

Primary care provider unwilling to have participant included in study; unable to give consent; severe mental health condition; living in a nursing home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)	one year

Secondary Outcome Measures

Name	Time	Method
incidence of end stage kidney disease	one year
hospital re-admission	one year
Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin	one year
reduction of cost	one year

Trial Locations

Locations (1)

VA Medical Center; 🇺🇸 Minneapolis, Minnesota, United States